Resources 2

Scientific Research: Publications

August 2026

Letter: FDA Approval of the HepQuant SHUNT Liver Diagnostic Test and Clarification of the SHUNT-V Analysis Cohort

Mitchell Shiffman, K. Rajender Reddy, Michael D. Leise, Kamran Qureshi, Alastair D. Smith, Steve Helmke, John Kittelson, Michael P. McRae, Joanne C. Imperial, Gregory T. Everson | Alimentary Pharmacology and Therapeutics

A recent Letter to the Editor provides additional context regarding the difference between the SHUNT-V study population reported in Alimentary Pharmacology & Therapeutics and the clinical validation dataset included in the FDA-approved labeling for the HepQuant SHUNT® Liver Diagnostic Test. read more →

July 2026

Simultaneous quantification of native human and transgenic porcine liver function in a decedent model of extracorporeal cross-circulation

Abraham Shaked, Michael P. McRae, Joanne C. Imperial, Leanne Lanieri, Alexander Sagar, Kim M. Olthoff, Susan Low, Kirsten G. Swenson, Peter Friend, Gregory T. Everson | American Journal of Transplantation

Porcine livers have the potential to support liver function via extracorporeal liver cross-circulation (ELC) until recovery or transplantation. To assess the functional integrity of both native human and porcine livers during ELC, we used the clearance of intravenously administered 13C-cholate to probe effective hepatic perfusion in 4 decedents maintained on ELC for 72 to 102 hours. Genetically modified porcine livers (EGEN-5784) were perfused using the OrganOx metra-ELC device. Hepatic filtration rate was calculated for the native human liver and the EGEN-5784 liver in ELC. During ELC, total hepatic filtration rate increased substantially compared with pre-ELC values, exceeded the upper limit of the normal range, and remained stable throughout the ELC period. Simultaneous measurement of cholate clearance in human and porcine livers during ELC provides real-time assessment of each organ’s functional contribution and may inform decisions regarding optimal ELC duration, timing of disconnection, and necessity of liver transplantation. read more →

May 2026

Evidence Supporting Utility of the Oral Cholate Challenge Test of Liver Function and Physiology to Aid Clinical Management: A Review of Analytical and Clinical Validation Studies

Andrew P. Keaveny, Kamran Qureshi, Mitchell Shiffman, Timothy R. Morgan, K. Rajender Reddy, Joanne C. Imperial, Michael P. McRae, Touraj Shokati, Gregory T. Everson | Gastro Hep Advances

Current liver assessments rely on liver stiffness measurements as surrogates for liver fibrosis or static laboratory values that reflect advanced disease or liver injury rather than overall hepatic function and physiology. The oral cholate challenge test (OCCT), HepQuant DuO® offers a noninvasive, blood-based, measure of liver function by assessing cholate clearance, which is hepatocyte specific and liver blood flow dependent. Clinical studies show its key metrics - Disease Severity Index (DSI), SHUNT%, and Hepatic Reserve - correlate with portal hypertension, varices, decompensation risk, and treatment response. These measures may outperform conventional liver tests and complement imaging or histology. The OCCT also shows promise as a monitoring tool in chronic liver disease drug trials, potentially improving both patient management and therapeutic development. read more →